ID
30859
Description
This ODM file contains Study Conclusion, Liver Event Check, Status of Treatment Blind, Pregnancy Information, Comment Log and Signature. To be filled if study concluded or withdrawal from study for any reason. Study ID: 109710 Clinical Study ID: DAN109710 Study Title: A single-blind, randomized, placebo controlled, two-period crossover fMRI study to investigate the effects of the D3 antagonist GSK598809 on neural and behavioural responses to food reward and reinforcement after a single oral dose of GSK598809 in overweight and obese subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01039454 https://clinicaltrials.gov/ct2/show/NCT01039454 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: GSK598809 Trade Name: Study Indication: Substance Dependence Brief Summary: This novel compound is a new experimental treatment that may help people to stop compulsive overeating. Compulsive overeating or binge eating is one of the main reasons why people are overweight or obese. Recent research has shown that some kinds of overeating may be linked to a brain chemical called dopamine. There is some evidence that blocking the action of this chemical in animals can reduce food intake, particularly of foods that are high in fat and sugar. The purpose of this study is to find out if this compound (which blocks the effects of dopamine) has the same effect in overweight or obese people, as it does in animals.
Link
https://clinicaltrials.gov/ct2/show/NCT01039454
Keywords
Versions (1)
- 6/27/18 6/27/18 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
June 27, 2018
DOI
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License
Creative Commons BY-NC 3.0
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Effects of D3 antagonist GSK598809 on neural and behavioural responses to food reward/reinforcement after a single dose in overweight/obese subjects NCT01039454
Study Conclusion, Liver Event Check, Status of Treatment Blind, Pregnancy Information, Comment Log
Description
Liver Events Assessment
Alias
- UMLS CUI-1
- C0232741
- UMLS CUI-2
- C0877248
- UMLS CUI-3
- C0220825
Description
To be checked on Session Days 1 pre-dose, 2 hours post-dose and 72 hours post-dose. If Yes, - Stop investigational product and complete date stopped on Investigational Product form. - Contact GSK within 24 hours of occurrence of liver event by phone or fax. - If the liver event meets the definition of an SAE, the SAE form must be completed and faxed to GSK. - Obtain tests as per protocol. - Obtain Blood sample for pharmacokinetic (PK) analysis within 24 hours of last dose. - Complete Liver Events Forms.
Data type
text
Alias
- UMLS CUI [1,1]
- C0232741
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C0220825
Description
Status of Treatment Blind
Alias
- UMLS CUI-1
- C3897431
Description
Treatment Blind Broken
Data type
text
Alias
- UMLS CUI [1]
- C3897431
Description
This is the date the Investigator is made aware of the blind being broken. Record either: Date blind was broken by Investigator or Date Investigator notified by GSK that the blind has been/was broken
Data type
date
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0011008
Description
Time blind broken
Data type
time
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0040223
Description
Complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product pages, as appropriate.
Data type
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
Description
Complete Non-Serious Adverse Events, Serious Adverse Event and/or Investigational Product pages, as appropriate.
Data type
text
Alias
- UMLS CUI [1,1]
- C3897431
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0205394
Description
Pregnancy Information
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Description
If Yes, complete Pregnancy Notification form. Not Applicable: not of childbearing potential or male
Data type
text
Alias
- UMLS CUI [1]
- C3828490
Description
If Yes, complete Pregnancy Notification form. Not Applicable: subject is female, female partner not of childbearing potential or no female partner)
Data type
text
Alias
- UMLS CUI [1,1]
- C3828490
- UMLS CUI [1,2]
- C0919624
Description
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
Description
Refer to protocol section(s) to evaluate subject completion or withdrawal from the study. If the subject completed the study: ’Date of last contact’ must match the last actual contact with the subject whether or not the contact was a clinic visit. If the subject withdrew from the study: ’Date of decision to withdraw’ must match the date of subject withdrawal. ’Date of last contact’ must match the last actual contact with the subject whether or not the contact was a clinic visit. Do not record dates of unsuccessful attempts to contact the subject. Note:An ’actual contact’ is defined as an interaction between the subject and the investigator or investigator’s designee, where the investigator/designee has the opportunity to query the subject about the subject’s status. This would include clinic visits and telephone contacts, but normally would not include mail correspondence or third party reports.
Data type
date
Alias
- UMLS CUI [1]
- C0805839
Description
Withdrawal from study
Data type
text
Alias
- UMLS CUI [1]
- C0422727
Description
If Adverse Event: Record details on the Non-Serious Adverse Events or Serious Adverse Event pages as appropriate. Withdrew consent: Only pick, if none of the other primary reasons are appropriate
Data type
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
Description
Reason for withdrawal
Data type
text
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0392360
- UMLS CUI [1,3]
- C0947611
Description
Date of decision to withdraw
Data type
date
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0679006
- UMLS CUI [1,3]
- C0011008
Description
Investigator Comment Log
Alias
- UMLS CUI-1
- C0008961
- UMLS CUI-2
- C0947611
Description
CRF page number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1704732
- UMLS CUI [1,2]
- C1516308
Description
Only use this to record explanatory information on anomalies such as missing data, departures from planned investigational product administration or missed visits.
Data type
text
Alias
- UMLS CUI [1]
- C0947611
Description
Investigator's signature
Alias
- UMLS CUI-1
- C2346576
Description
Investigator's signature
Data type
text
Alias
- UMLS CUI [1]
- C2346576
Description
Investigator's name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Signature Date
Data type
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
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Study Conclusion, Liver Event Check, Status of Treatment Blind, Pregnancy Information, Comment Log
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C0220825 (UMLS CUI-3)
C0877248 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0040223 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0919624 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0392360 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C0947611 (UMLS CUI-2)
C1516308 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
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